Cardiac Surgery and Diaphragm Function

NCT02208479 | Completed

• 1 other identifier: 2014-13
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress. The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation. The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.

Conditions

Cardiac Surgery

Keywords

cardiac surgery; diaphragm dysfunction; mechanical ventilation weaning; respiratory paralysis; muscle weakness; cardiac bypass; valvular surgery; respiratory insufficiency

Outcome Measures

Primary Outcomes (1)

• Diaphragm inspiratory thickening fraction

  At the begining of the spontaneous breathing trial (around 4hours after surgery)

Secondary Outcomes (4)

• Diaphragm dysfunction before surgery

  the day before surgery

• Severity score (Euroscore)

  the day before surgery

• extracorporeal circulation duration

  peroperative

• left ventricular ejection fraction

  the day before surgery

Study Arms (1)

cardiac surgery

Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing

Interventions

Non invasive ultrasound measurement of the diaphragm thickness during breathing OTHER

cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery

You may qualify if:

• years old and older
• planned surgery
• ready for weaning from mechanical ventilation

You may not qualify if:

• protected patient
• patient refusal

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Unité de Réanimation Cardio-vasculaire et Thoracique

Grenoble, 38043, France

Location

Related Publications (4)

• DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

  PMID: 24365607 BACKGROUND

• McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available.

  PMID: 22397655 BACKGROUND

• Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

  PMID: 20813887 BACKGROUND

• Moury PH, Cuisinier A, Durand M, Bosson JL, Chavanon O, Payen JF, Jaber S, Albaladejo P. Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study. Ann Intensive Care. 2019 Apr 24;9(1):50. doi: 10.1186/s13613-019-0521-z.

  PMID: 31016412 DERIVED

MeSH Terms

Conditions

Respiratory Paralysis; Muscle Weakness; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

FR (1)